Cleared Traditional

K961644 - MINIOX 3000 OXYGEN MONITOR

K961644 is the FDA 510(k) clearance for MINIOX 3000 OXYGEN MONITOR by Minesafety Appliances Co.. It is a Class 2 Anesthesiology device (product code CCL) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K961644 · Minesafety Appliances Co. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Jul 1996
Decision
87d
Days
Class 2
Risk

K961644 is an FDA 510(k) clearance for the MINIOX 3000 OXYGEN MONITOR. Classified as Analyzer, Gas, Oxygen, Gaseous-phase (product code CCL), Class II - Special Controls.

Submitted by Minesafety Appliances Co. (Mars, US). The FDA issued a Cleared decision on July 25, 1996 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1720 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Minesafety Appliances Co. devices

Submission Details

510(k) Number K961644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1996
Decision Date July 25, 1996
Days to Decision 87 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 140d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CCL Analyzer, Gas, Oxygen, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1720
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - CCL Analyzer, Gas, Oxygen, Gaseous-phase

All 20
Devices cleared under the same product code (CCL) and FDA review panel - the closest regulatory comparables to K961644.
SIEMENS FIO2 SENSOR
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K982619 · Hewlett-Packard Co. · Aug 1998
COMPANION RETROFIT OXYGEN CONCENTRATION INDICATOR
K920338 · Puritan Bennett Corp. · Aug 1992
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K896359 · Nihon Kohden America, Inc. · Mar 1990
MULTINEX MONITOR (MODIFICATION)
K883254 · Datascope Corp. · Sep 1988